BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVOSET INFUSION PUMP ROW

    MDR report key: 21688180 · Received March 25, 2025

    Report

    Report Number
    3010293992-2025-00023
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    March 12, 2025
    Report Date
    June 29, 2025
    Manufacturer
    EITAN MEDICAL LTD.
    Product Code
    FRN
    UDI-DI
    7290109152097
    PMA / PMN Number
    K213744
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION TYPE: EITAN MEDICAL INVESTIGATED THE PUMP INVOLVED IN THIS EVENT. INVESTIGATION FINDINGS: THE INVESTIGATION FOUND THE PUMP TO MEET SPECIFICATIONS. CONCLUSION: AS THE PUMP WAS FOUND TO MEET SPECIFICATIONS, IT IS POSSIBLE THAT THE USER'S TREATMENT WAS AFFECTED BY EXTERNAL FACTORS. THIS REPORTED EVENT OCCURRED OUTSIDE OF THE US ON A DEVICE THAT IS SIMILAR TO THE ONE MARKETED IN THE US AND FOR WHICH THERE IS NO DATA IN GUDID. DEVICE'S PREMARKET SUBMISSION NUMBER: K213744.

    Additional Manufacturer Narrative · 0

    INVESTIGATION TYPE: EITAN MEDICAL INVESTIGATED THE PUMP'S EVENT LOG. INVESTIGATION FINDINGS: THE COMPLAINT WAS NOT CONFIRMED. ACCORDING TO THE EVENT LOG, THE PUMP INFUSED WITHIN ACCURACY SPECIFICATIONS. CONCLUSION: ACCORDING TO THE EVENT LOG, THE PUMP INFUSED WITHIN ACCURACY SPECIFICATIONS. EITAN MEDICAL REQUESTED THE PUMP TO BE RECEIVED FOR INVESTIGATION. WHEN RECEIVED, THE PUMP WILL BE TESTED, AND THE TEST RESULTS WILL BE PRESENTED IN A FOLLOW UP REPORT. THIS REPORTED EVENT OCCURRED OUTSIDE OF THE US ON A DEVICE THAT IS SIMILAR TO THE ONE MARKETED IN THE US AND FOR WHICH THERE IS NO DATA IN GUDID. DEVICE'S PREMARKET SUBMISSION NUMBER: K213744.

    Additional Manufacturer Narrative · 0

    THIS REPORTED EVENT OCCURRED OUTSIDE OF THE US ON A DEVICE THAT IS SIMILAR TO THE ONE MARKETED IN THE US AND FOR WHICH THERE IS NO DATA IN GUDID. DEVICE'S PREMARKET SUBMISSION NUMBER: K213744.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE. A DELIVERY ISSUE WAS REPORTED. THE CUSTOMER STATED THAT NO HUMAN HARM OCCURRED. NO MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE. A DELIVERY ISSUE WAS REPORTED. THE CUSTOMER STATED THAT NO HUMAN HARM OCCURRED. NO MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    THE COMPLAINT WAS REPORTED BY A CUSTOMER FROM FRANCE. DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1319076 AVOSET INFUSION PUMP ROW INFUSION PUMP FRN EITAN MEDICAL LTD. 7290109152097

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown